Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
NCT07916675, Not yet recruiting, Ankara City Hospital Bilkent
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients | ClinicalTrials.gov |
| NCT number | NCT07916675 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 450 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ankara City Hospital Bilkent | ClinicalTrials.gov |
| Conditions | Frailty, Suboptimal Mask Ventilation | ClinicalTrials.gov |
| Interventions | Mask Ventilation During Routine Anesthesia Induction | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Association Between Preoperative Frailty and Suboptimal Mask Ventilation in Patients Aged 60 Years and Older Undergoing Elective Cardiac Surgery | Preoperative frailty assessment and the first 20 breaths of mask ventilation following induction of general anesthesia, before endotracheal intubation. | Preoperative frailty will be assessed using the 9-point Clinical Frailty Scale (CFS; scores 1-9). Patients with CFS ≥4 will be classified as vulnerable/frail and those with CFS \<4 as the comparison group. Suboptimal mask ventilation (SMV) will be assessed during the first 20 breaths of face-mask ventilation after induction of general anesthesia and before endotracheal intubation. SMV will be defined by ≥1 of the following: 1. Exhaled tidal volume \<5 mL/kg ideal body weight. 2. Absent or inadequate end-tidal CO2 waveform. 3. Need for two-person mask ventilation. 4. Need for an oropharyngeal or nasopharyngeal airway. 5. SpO2 \<92%. SMV will be recorded as a binary outcome (yes/no). SMV occurrence will be compared between CFS groups, and its association with frailty will be assessed using multivariable logistic regression. | ClinicalTrials.gov |
| Secondary | Incremental Predictive Value of Handgrip Strength Beyond Preoperative Frailty for Suboptimal Mask Ventilation | Preoperative CFS and handgrip strength assessment and the first 20 breaths of mask ventilation following induction of general anesthesia. | The incremental predictive value of preoperative handgrip strength beyond frailty assessment using the Clinical Frailty Scale (CFS) will be investigated for the occurrence of suboptimal mask ventilation (SMV) following induction of general anesthesia. Preoperative frailty will be assessed using the 9-point CFS. Patients with CFS scores ≥4 will be classified as belonging to the vulnerable/frail spectrum, while patients with CFS scores \<4 will form the comparison group. Handgrip strength will be assessed using the mean of three measurements obtained from the dominant hand with a calibrated hand dynamometer. Multivariable logistic regression models will be used to evaluate whether the addition of handgrip strength to frailty assessment improves the prediction of SMV. Receiver operating characteristic (ROC) curve analyses will be performed to compare model discrimination. The area under the ROC curve (AUC) will be used to evaluate the additional predictive value of handgrip strength b | ClinicalTrials.gov |
| Secondary | Association Between Suboptimal Mask Ventilation and Tracheal Intubation Difficulty | During the first 20 breaths of mask ventilation and subsequent tracheal intubation following induction of general anesthesia. | The association between suboptimal mask ventilation (SMV) and subsequent tracheal intubation difficulty will be investigated in patients aged 60 years and older undergoing elective cardiac surgery. SMV will be assessed during the first 20 breaths following induction of general anesthesia according to the predefined criteria. During subsequent tracheal intubation, the following parameters will be recorded: 1. Laryngoscopic view according to the Cormack-Lehane classification (Grades I-IV). 2. Number of tracheal intubation attempts. 3. First-attempt intubation success (yes/no). The distribution of Cormack-Lehane grades, number of intubation attempts, and first-attempt intubation success will be compared between patients with and without SMV. The relationship between SMV and these indicators of tracheal intubation difficulty will be evaluated using appropriate statistical analyses. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)